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U.S. Department of Health and Human Services

Medical Devices

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Standards (Medical Devices)

CDRH Standards Program/Standards Management Staff

Office of the Center Director

  • 301-796-6574
  • Building 66, Room 3632

The mission of the Standards Management Staff (SMS) is to:

The Standards Management Staff (SMS) is responsible for facilitating the recognition of national and international medical device consensus standards. CDRH is invested in the development of medical device standards and participates significantly in the development process. SMS manages the Standards Program, a regulatory support activity consisting of cross-office teams within CDRH and FDA. This involves working closely with the Standards Developing Organizations (SDOs), advertising standards liaison representative positions, facilitating a Center recommendation to serve on a particular standards activity, and maintaining an appropriate standards database providing access to established standards for all CDRH staff, field inspectors, and industry. SMS continually updates currently recognized standards and coordinates the recognition of new voluntary consensus standards for medical devices and radiation-emitting electronic products. SMS ensures appropriate medical device standards are published in the Federal Register at least twice annually. The Standards Program was created as a result of the Food and Drug Administration Modernization Act (FDAMA) of 1997. Although CDRH had been involved in the development of medical device standards for decades, FDAMA formalized the process.


Organization:

Director Scott Colburn 301-796-6287
Deputy Director Sharon Lappalainen 301-796-6322
Public Health Advisor Terri D. Bailum 301-796-6574
Public Health Advisor Maureen Gallagher 301-796-6575
Standards Coordinator Patricio Garcia 301-796-6875
Standards Coordinator Jianchao Zeng 301-796-6580
Standards Coordinator Ponleaarun (Arun) Le 301-796-0458
Standards Coordinator Martha O'Lone 301-796-0457

 

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